Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting
2 other identifiers
interventional
800
1 country
1
Brief Summary
This is a 3-arm randomized trial aimed at increasing rates of participation in colorectal cancer (CRC) screening by outreach to patients' homes using choice architecture informed by behavioral science principles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Oct 2021
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 15, 2021
CompletedStudy Start
First participant enrolled
October 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2022
CompletedJanuary 13, 2023
January 1, 2023
1 year
January 12, 2021
January 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Colorectal Cancer Screening Completion
Screening completion rate in arm 2 (Choice) to arm 1 (Colonoscopy only) and arm 3 (FIT only) separately.
6 months from initial outreach
Secondary Outcomes (1)
Choice of Colorectal Cancer Screening Test
6 months from initial outreach
Study Arms (3)
Colonoscopy Only
ACTIVE COMPARATORParticipants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in colonoscopy, and including a referral for the procedure at a local endoscopy center. Participants will be provided a phone number if interested in navigated colonoscopy scheduling.
Choice
EXPERIMENTALParticipants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in their choice of either colonoscopy or mailed fecal immunochemical testing (FIT). The letter will include both a referral for the colonoscopy at a local endoscopy enter and a FIT kit with a lab requisition and instructions for completion.
FIT Only
EXPERIMENTALParticipants in this arm will receive a letter from their provider informing them they are overdue for colon cancer screening and requesting their participation in FIT testing. The letter will include a FIT kit with lab requisition and instructions for completion.
Interventions
Mailed letter asking participants to complete CRC screening by colonoscopy
Mailed letter and FIT test asking participants to complete CRC screening by their choice of either colonoscopy or mailed FIT
Mailed letter and FIT test asking participants to complete CRC screening by mailed FIT
Eligibility Criteria
You may qualify if:
- At least 1 visit with CHDC in the past 2 years
- Not up to date on CRC screening (no evidence of colonoscopy in the last 10 years, sigmoidoscopy in the last 5 years, or stool testing in the past 12 months)
You may not qualify if:
- History of CRC or polyps
- Significant family history of CRC
- History of Inflammatory Bowel Disease or Ulcerative Colitis
- History of colectomy
- History of metastatic cancer
- Current use of Medication Assisted Therapy (MAT)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Community Health and Dental Care
Pottstown, Pennsylvania, 19465, United States
Related Publications (1)
Mehta SJ, Palat S, McDonald C, Reitz C, Okorie E, Williams K, Tao J, Shaw PA, Glanz K, Asch DA. A Randomized Trial of Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting. Clin Gastroenterol Hepatol. 2024 Oct;22(10):2117-2124.e2. doi: 10.1016/j.cgh.2024.04.003. Epub 2024 Apr 30.
PMID: 38697235DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shivan Mehta, MD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 12, 2021
First Posted
January 15, 2021
Study Start
October 27, 2021
Primary Completion
November 11, 2022
Study Completion
November 11, 2022
Last Updated
January 13, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share